SK Biopharmaceuticals’ epilepsy drug Cenobamate will soon be reviewed for approval in Canada and Israel.

SK Biopharmaceuticals will begin to undergo the approval process of its new epilepsy drug, Cenobamate, in Canada and Israel.
SK Biopharmaceuticals will begin to undergo the approval process of its new epilepsy drug, Cenobamate, in Canada and Israel.

Paladin Labs, a subsidiary of SK Biopharma’s partner company Endo International, sent new drug submission (NDS) for the innovative novel drug for epilepsy to Health Canada in June.

If the Canadian regulator approves the NDS approval, SK Biopharma will begin commercializing Cenobamate in the North American country. Paladin Labs, a Canada-based pharmaceutical company, will commercialize the drug in its country.

SK Biopharma signed a license agreement with Endo Ventures, an Ireland-headquartered pharmaceutical company Endo International Group subsidiary, and is licensing and commercializing Cenobamate in Canada. Accordingly, the company expects to secure additional benefits from supplying Cenobamate and receive milestones.

SK Biopharma’s other partner, Dexcel Pharma, also said it submitted an approval application for Cenobamate to Israel and would undergo an official review soon.

In Israel, winning a novel drug approval is relatively easy if the treatment candidate has already received approval from the U.S. Food and Drug Administration, according to SK Biopharma.

“Therefore, we expect its commercialization in Israel to proceed quickly,” the company said.

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